Patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism or relapse after hematopoietic stem cell transplantation.
Conditions
Interventions
Product Name: Vidaza
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: 5-Azacytidin
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number:
Sponsors
University of Technology Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > 18 years - Patients with CD34+ acute myeloid leukaemia or myelodysplastic syndrome after hematopoietic stem cell transplantation - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Known or current abuse of drugs, medications or alcohol - Subjects unlikely to comply with the requirements of the protocol - Pregnancy or lactation - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using a highly effective method of birth control (defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner - Participation in another clinical trial within the last four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism or relapse after hematopoietic stem cell transplantation.;Secondary Objective: Savety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism or relapse after hematopoietic stem cell transplantation.;Primary end point(s): Primary end point: Increase of CD34-chimerism > 80% 3 month after the last cycle of 4 cycles 5-Azacytidin or achievement of < 5% blasts in bone marrow 3 month after the last cycle of 4 cycles 5-Azacytidin | — |
Countries
Germany
Outcome results
None listed